Cognitive ImpairmentNCT04047238
Multicentre Study About the Effect of Individual Reminiscence Therapy
A study testing Reminiscence Therapy in people with Cognitive Impairment and Cognitive Decline, run by Rsocialform - Geriatria, Lda at 25 sites in Portugal.
Trial summary
This study aims to evaluate the effect of individual reminiscence therapy (RT) on the global cognitive function of people with neurocognitive disorders attending social responses and to evaluate the ability of individually applied reminiscence therapy (RT) to improve overall cognitive function, memory, executive… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cognitive Impairment, Cognitive Decline, Dementia
- What is being tested?
- Reminiscence Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 251 participants
- Where
- 25 sitesPortugal
- Study dates
- 8 Aug 2019to 20 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Having a diagnostic of a neurocognitive disorder according to the DSM-5 criteria.
- To have delivered the informed consent of the project, duly completed and signed, after prior information
- Capacity to communicate and understand.
- Possibility of gathering information about the participant's life history through their relatives or habitual caregivers, using the socio-familiar questionnaire design for that purpose.
- Being 65 years of age or older.
- Being a native Portuguese speaker.
- Regularly attend a social response institution that provides services for the elderly.
Who cannot join
- To suffer from an acute or severe illness that makes it impossible for them to participate in the intervention sessions.
- Serious sensory and physical limitations that prevent the participation in the sessions.
- Severe disconnection with the environment and very limited attention span.
- Presence of severe neuropsychiatric symptoms, such as hyperactivity, psychosis, severe depressive and anxiety symptoms and apathy, that prevent participation in the sessions or presence of uncontrolled delirium.
- Traumatic life history or marked by negative events relevant to the person that discourage the participation in the Reminiscence Therapy sessions.
- History of negative reactions during previous Reminiscence Therapy sessions or similar activities.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Portugal25 sites
Cediara - Assoc. Sol. Social de Ribeira de Fráguas
Albergaria-a-Velha, Aveiro District, 3850-705
Santa Casa Da Misericordia de Almada - Centro São Lázaro
Almada, Setúbal District, 2800-119
Centro Social Vale Do Homem
Braga, 4730-263
Santa Casa Da Misericórdia de Vila Verde
Braga, 4730-416
Centro Zulmira Pereira Simões
Braga, 4750-650
Santa Casa Da Misericórdia de Castelo Branco
Castelo Branco, 6000-773
Santa Casa Da Misericórdia de Vila Velha de Ródão
Castelo Branco, 6030-230
APARSIN - Assoc. Port. de Apoio e Reabilitação Sénior de Intervenção Neurológica
Elvas, Portalegre District, 7350
Centro Social Paroquial Dornelas
Guarda, 3570-130
Primavida Residência Sénior Amor
Leiria, 2400-792
Santa Casa Da Misericórdia de Alcobaça
Leiria, 2460-009
Santa Casa Da Misericórdia Do Alvorge
Leiria, 3240-407
Associação Alzheimer Portugal
Lisbon, 1300-125
Irmãs Hospitaleiras - Casa de Saúde Da Idanha
Lisbon, 2605-077
Rsocialform - Geriatria, Lda.
Mealhada, Aveiro District, 3050-387
Santa Casa Da Misericórdia de Ovar
Ovar, Aveiro District, 3880-225
Centro Social de Tolosa
Portalegre, 6050-501
Delicate Age Lda.
Portimão, Faro District, 8500-684
Centro Social Paroquial Recarei
Porto, 4585-905
Associação de Solidariedade Social S. Tiago de Rebordões
Porto
Lar D. Pedro V
Praia da Vitória, Azores, 9760-458
Santa Casa Da Misericordia de Coruche
Santarém, 2100-111
Santa Casa Da Misericórdia de Melgaço
Viana do Castelo, 4960-529
Santa Casa Da Misericórdia de Vouzela
Viseu, 3670-257
Pesqueiramiga- Associação de Solidariedade Social
Viseu, 5130-376
About this study
Official title: Multicentre Randomized Controlled Study About the Effect of Individual Reminiscence Therapy on Cognition in Elderly People With Neurocognitive Disorder Attending Social Responses
This study aims to evaluate the effect of individual reminiscence therapy (RT) on the global cognitive function of people with neurocognitive disorders attending social responses and to evaluate the ability of individually applied reminiscence therapy (RT) to improve overall cognitive function, memory, executive function, mood and quality of life (QoL) of elderly people with neurocognitive impairment attending social responses. It is proposed a multicenter study with an experimental design with randomized controlled repeated measures. Participants in the intervention group will hold two RT sessions per week for three months. Control group participants will maintain their treatment as usual.
Read the detailed description
Neurocognitive disorder is a major cause of disability among older people and its incidence is increasing due to an aging population. Neurocognitive disorders globally are estimated to affect 44.35 million people and it is expected that by the year 2050 the number of affected people globally will triple to 135.46 million.
The absence of effective pharmacological treatment that stops or slows down the development of the disease has aroused interest in non-pharmacological therapies as a complement to pharmacological treatment that may improve the quality of life of people with neurocognitive disorders. One of the most investigated and most traditional non-pharmacological therapy in this field is Reminiscence Therapy (RT).
RT involves discussing past activities, events and experiences, usually with the help of triggers, such as photographs, household objects and other familiar items from the past, music… that is, any object or stimulus that serves to stimulate remembrance. In its application to dementia, RT is based on the fact that the memory impairment of people with dementia means that they are able to recall events from their past life, especially from childhood to early adulthood, but cannot remember more recent facts. It focuses on preserved memories and abilities, promotes communication, and enables the person to connect with his/her past and regain his/her sense of personal identity. Thus, RT can be understood as an intervention on the edge of those of cognitive orientation and emotion-centered, with potential interactive effects on autobiographical memory and psychological well-being.
The investigators can distinguish at least two RT approaches. The first one is the "life review" where participants are guided through meaningful experiences from their biography trying to make sense of their life. This type of RT is more structured and is usually conducted in an individual format. It may imply the construction of "life books". This approach is considered to have an integrative function aimed at achieving a sense of validation, coherence and reconciliation with the person's past. Another approach is the simple reminiscence which involves the stimulation of autobiographical memory during conversations about specific themes of the past (such as holidays, food and drinks, work…) using stimuli that trigger memories. It has been described as an unstructured narrative of autobiographical memories. This reminiscence format can be conducted both individually and in groups and promotes communication between participants who share their memories and stories.
In any of the TR formats it is essential to introduce triggering stimuli (photographs, music, antique objects…) to aid in recall. These triggers may be generic, reflecting common experiences in the lives of people relevant to their age group (for example a textbook may serve to recall the experience during their school stage), or specific, with stimuli related to the individual's own experiences (for example photographs of an important life event such as your wedding day or a trip during your youth).
Regarding the effectiveness of RT, according to a recent Cochrane review, there is some evidence for its positive effects on cognition, QoL, communication, and possibly mood of people with dementia, although benefits are small. Despite the distinction between the two different approaches to RT (simple reminiscence vs. life review), the modality of therapy does not seem to be as important for positive effects as the individual or group format of the sessions and the context in which the intervention is administered (people who live in the community or people who are institutionalized).
According to the results of one review study, RT seems to be able to generate a small benefit on cognitive function immediately after the intervention, although it usually does not persist after a follow-up period. Regarding the administration format, individual RT effects seems slightly superior on cognition both immediately and after a follow-up period. In any case, its effects appear to be comparable to those of other cognitive stimulation therapies.
As for the effect of RT on QoL, a life-review-based individual RT study showed an improvement in Qol-AD. Effects with a group format do not seem consistent, showing little or no effect on QoL, although the key factor may be the application context (community vs. institution), with better results of group RT in institutionalized patients.
Group RT was associated with an effect on communication both after the intervention and at follow-up. This effect was not replicated in individual RT, with uncertain results.
Finally, despite evidence of the effect of RT on mood of older people without dementia, in the case of people with dementia only a small effect on mood was found for those participants. in individual RT.
Therefore, this research proposal aims to evaluate the ability of individual RT using a simple reminiscence format to improve the overall cognitive function, memory, executive function, mood and quality of life (QoL) of people with neurocognitive disorder attending social responses for the elderly.
- Being tested
- Reminiscence Therapy
- Keywords
- Dementia, Cognitive Impairment, Cognitive Decline, Neurocognitive Disorders, Elderly, Reminiscence Therapy, Individual Intervention, Cognition, Depression, Quality of Life
- Medical subject headings
- Cognitive Dysfunction, Dementia, Neurocognitive Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reminiscence TherapyOther
Intervention group will receive two Reminiscence Therapy sessions per week for 3 months. Reminiscence therapy sessions will last approximately 50 minutes and will be developed according to the following structure:
- Welcome to the patient and reality orientation therapy (7 minutes)
- Conducting the main activity of reminiscence (40 minutes)
- Closure, thank you for the participation and farewell until the next session (3 minutes) Reminiscence therapy sessions will have an individual format and will be conducted by a therapist previously trained in the protocol and the principles of Reminiscence Therapy. The Reminiscence activities of each session will be carried out following the protocol proposed in the Book of Past and Present.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants who meet the inclusion criteria will be randomly assigned to the intervention group receiving Reminiscence Therapy or to a control group receiving treatment as usual. Participants in the intervention group will participate in two Reminiscence Therapy sessions per week for 3 months besides their treatment as usual. The sessions will be based on the Book of Past and Present and they will follow the same protocol in every participant institution. Receives: Other: Reminiscence Therapy |
| Control Group | No intervention | Participants assigned to the control group will maintain their usual treatment in the institution, participating in the activities previously assigned to their individual care plan. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive functioning evaluated through Mini-Mental State Examination
Significant statistic improvement in the participant's test scores between pre-intervention assessment and post-intervention assessment. Mini-Mental State Examination is a brief cognitive screening test. Scores range between 0 - 30 points. Higher scores indicate better cognitive function.
Measured: Pre and post-intervention (3 months)
Secondary outcomes (4)
Memory funtion evaluated through Memory Alteration Test
Significant statistic improvement in the participant's test scores between pre-intervention assessment and post-intervention assessment. Memory Alteration Test is an easy and fast instrument that assesses five memory domains: orientation in time, short term memory, semantic memory, free recall and recall with clues. Scores range between 0 - 50 points. Higher scores indicate better memory.
Measured: Pre and post-intervention (3 months)
Executive functions evaluated through Frontal Assessment Battery
Significant statistic improvement in the participant's test scores between pre-intervention assessment and post-intervention assessment. Frontal Assessment Battery assesses executive functions such as abstract thinking, mental flexibility, motor programming, interference sensibility, inhibitory control and environmental independence. Scores range between 0 - 18 points. Higher scores indicate better cognitive function.
Measured: Pre and post-intervention (3 months)
Mood evaluated through Geriatric Depression Scale -15
Significant statistic improvement in the participant's test scores between pre-intervention assessment and post-intervention assessment. Geriatric Depression Scale -15 is composed by 15 yes/no answer items and it has good psychometric characteristics to assess depression in older people. Scores range between 0 - 15 points. Higher scores indicate more severe depressive symptoms.
Measured: Pre and post-intervention (3 months)
Quality of life evaluated through Quality of Life - Alzheimer's Disease
Significant statistic improvement in the participant's test scores between pre-intervention assessment and post-intervention assessment. Quality of Life - Alzheimer's Disease is an instrument to assess quality of life in people diagnosed with dementia, gathering information from the patient and the caregiver. It is composed by 13 items regarding perception of health, mood, functional abilities, interpersonal relationships and hobbies, decision making ability and life in general. It has good psychometric characteristics and it's use has been recommended to evaluate psychossocial interventions. Scores range between 13 - 52 points. Higher scores indicate better quality of life.
Measured: Pre and post-intervention (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start8 Aug 2019
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rsocialform - Geriatria, Lda
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susana I Justo Henriques, PhD, Principal investigator, Cediara and University of de Santiago de CompostelaEnrique Pérez Sáez, PhD, Principal investigator, CRE Alzheimer and University of SalamancaJoão L Alves Apóstolo, PhD, Principal investigator, Nursing School of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04047238
- Sponsor's protocol ID
- 01082019
- Status last verified
- Aug 2019
- First submitted
- 2 Aug 2019
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akanuma K, Meguro K, Meguro M, Sasaki E, Chiba K, Ishii H, Tanaka N. Improved social interaction and increased anterior cingulate metabolism after group reminiscence with reality orientation approach for vascular dementia. Psychiatry Res. 2011 Jun 30;192(3):183-7. doi: 10.1016/j.pscychresns.2010.11.012. Epub 2011 May 4.
PubMed 21543189Amieva H, Robert PH, Grandoulier AS, Meillon C, De Rotrou J, Andrieu S, Berr C, Desgranges B, Dubois B, Girtanner C, Joel ME, Lavallart B, Nourhashemi F, Pasquier F, Rainfray M, Touchon J, Chene G, Dartigues JF. Group and individual cognitive therapies in Alzheimer's disease: the ETNA3 randomized trial. Int Psychogeriatr. 2016 May;28(5):707-17. doi: 10.1017/S1041610215001830. Epub 2015 Nov 17.
PubMed 26572551Apóstolo JLA, Loureiro LMJ, Reis IAC, Silva IALL, Cardoso DFB, Sfetcu R. Contribution to the adaptation of the Geriatric Depression Scale -15 into Portuguese. Revista de Enfermagem Referência IV(3): 65-73, 2014. doi: 10.12707/RIV14033.
Serrani Azcurra DJ. A reminiscence program intervention to improve the quality of life of long-term care residents with Alzheimer's disease: a randomized controlled trial. Braz J Psychiatry. 2012 Dec;34(4):422-33. doi: 10.1016/j.rbp.2012.05.008.
PubMed 23429813Barrios H, Verdelho A, Narciso S, Goncalves-Pereira M, Logsdon R, de Mendonca A. Quality of life in patients with cognitive impairment: validation of the Quality of Life-Alzheimer's Disease scale in Portugal. Int Psychogeriatr. 2013 Jul;25(7):1085-96. doi: 10.1017/S1041610213000379. Epub 2013 Mar 27.
PubMed 23534370Caddell LS, Clare L. The impact of dementia on self and identity: a systematic review. Clin Psychol Rev. 2010 Feb;30(1):113-26. doi: 10.1016/j.cpr.2009.10.003.
PubMed 19896760Charlesworth G, Burnell K, Crellin N, Hoare Z, Hoe J, Knapp M, Russell I, Wenborn J, Woods B, Orrell M. Peer support and reminiscence therapy for people with dementia and their family carers: a factorial pragmatic randomised trial. J Neurol Neurosurg Psychiatry. 2016 Nov;87(11):1218-1228. doi: 10.1136/jnnp-2016-313736. Epub 2016 Aug 12.
PubMed 27521377Dempsey L, Murphy K, Cooney A, Casey D, O'Shea E, Devane D, Jordan F, Hunter A. Reminiscence in dementia: a concept analysis. Dementia (London). 2014 Mar 1;13(2):176-92. doi: 10.1177/1471301212456277. Epub 2012 Aug 17.
PubMed 24599812Dubois B, Slachevsky A, Litvan I, Pillon B. The FAB: a Frontal Assessment Battery at bedside. Neurology. 2000 Dec 12;55(11):1621-6. doi: 10.1212/wnl.55.11.1621.
PubMed 11113214Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
PubMed 1202204Gonzalez J, Mayordomo T, Torres M, Sales A, Melendez JC. Reminiscence and dementia: a therapeutic intervention. Int Psychogeriatr. 2015 Oct;27(10):1731-7. doi: 10.1017/S1041610215000344. Epub 2015 Mar 13.
PubMed 25765779Haight BK, Gibson F, Michel Y. The Northern Ireland life review/life storybook project for people with dementia. Alzheimers Dement. 2006 Jan;2(1):56-8. doi: 10.1016/j.jalz.2005.12.003.
PubMed 19595856Kirk M, Berntsen D. A short cut to the past: Cueing via concrete objects improves autobiographical memory retrieval in Alzheimer's disease patients. Neuropsychologia. 2018 Feb;110:113-122. doi: 10.1016/j.neuropsychologia.2017.06.034. Epub 2017 Jul 1.
PubMed 28676268Kirk M, Rasmussen KW, Overgaard SB, Berntsen D. Five weeks of immersive reminiscence therapy improves autobiographical memory in Alzheimer's disease. Memory. 2019 Apr;27(4):441-454. doi: 10.1080/09658211.2018.1515960. Epub 2018 Sep 8.
PubMed 30198380Lai CK, Chi I, Kayser-Jones J. A randomized controlled trial of a specific reminiscence approach to promote the well-being of nursing home residents with dementia. Int Psychogeriatr. 2004 Mar;16(1):33-49. doi: 10.1017/s1041610204000055.
PubMed 15190995
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Randomized Controlled Study About the Effect of Individual Reminiscence Therapy on Cognition in Elderly People With Neurocognitive Disorder Attending Social Responses
- ClinicalTrials.gov ID
- NCT04047238
- Acronym / sponsor ID
- 01082019
- Keywords
- Dementia, Cognitive Impairment, Cognitive Decline, Neurocognitive Disorders, Elderly, Reminiscence Therapy, Individual Intervention, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- Rsocialform - Geriatria, LdaUniversity, hospital or other
- Study start
- 8 Aug 2019 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 6 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the effect of individual reminiscence therapy (RT) on the global cognitive function of people with neurocognitive disorders attending social responses and to evaluate the ability of individually applied reminiscence therapy (RT) to improve overall cognitive function, memory, executive function, mood and quality of life (QoL) of elderly people with neurocognitive impairment attending social responses. It is proposed a multicenter study with an experimental design with randomized controlled repeated measures. Participants in the intervention group will hold two RT sessions per week for three months. Control group participants will maintain their treatment as usual.
Detailed description
Neurocognitive disorder is a major cause of disability among older people and its incidence is increasing due to an aging population. Neurocognitive disorders globally are estimated to affect 44.35 million people and it is expected that by the year 2050 the number of affected people globally will triple to 135.46 million.
The absence of effective pharmacological treatment that stops or slows down the development of the disease has aroused interest in non-pharmacological therapies as a complement to pharmacological treatment that may improve the quality of life of people with neurocognitive disorders. One of the most investigated and most traditional non-pharmacological therapy in this field is Reminiscence Therapy (RT).
RT involves discussing past activities, events and experiences, usually with the help of triggers, such as photographs, household objects and other familiar items from the past, music… that is, any object or stimulus that serves to stimulate remembrance. In its application to dementia, RT is based on the fact that the memory impairment of people with dementia means that they are able to recall events from their past life, especially from childhood to early adulthood, but cannot remember more recent facts. It focuses on preserved memories and abilities, promotes communication, and enables the person to connect with his/her past and regain his/her sense of personal identity. Thus, RT can be understood as an intervention on the edge of those of cognitive orientation and emotion-centered, with potential interactive effects on autobiographical memory and psychological well-being.
The investigators can distinguish at least two RT approaches. The first one is the "life review" where participants are guided through meaningful experiences from their biography trying to make sense of their life. This type of RT is more structured and is usually conducted in an individual format. It may imply the construction of "life books". This approach is considered to have an integrative function aimed at achieving a sense of validation, coherence and reconciliation with the person's past. Another approach is the simple reminiscence which involves the stimulation of autobiographical memory during conversations about specific themes of the past (such as holidays, food and drinks, work…) using stimuli that trigger memories. It has been described as an unstructured narrative of autobiographical memories. This reminiscence format can be conducted both individually and in groups and promotes communication between participants who share their memories and stories.
In any of the TR formats it is essential to introduce triggering stimuli (photographs, music, antique objects…) to aid in recall. These triggers may be generic, reflecting common experiences in the lives of people relevant to their age group (for example a textbook may serve to recall the experience during their school stage), or specific, with stimuli related to the individual's own experiences (for example photographs of an important life event such as your wedding day or a trip during your youth).
Regarding the effectiveness of RT, according to a recent Cochrane review, there is some evidence for its positive effects on cognition, QoL, communication, and possibly mood of people with dementia, although benefits are small. Despite the distinction between the two different approaches to RT (simple reminiscence vs. life review), the modality of therapy does not seem to be as important for positive effects as the individual or group format of the sessions and the context in which the intervention is administered (people who live in the community or people who are institutionalized).
According to the results of one review study, RT seems to be able to generate a small benefit on cognitive function immediately after the intervention, although it usually does not persist after a follow-up period. Regarding the administration format, individual RT effects seems slightly superior on cognition both immediately and after a follow-up period. In any case, its effects appear to be comparable to those of other cognitive stimulation therapies.
As for the effect of RT on QoL, a life-review-based individual RT study showed an improvement in Qol-AD. Effects with a group format do not seem consistent, showing little or no effect on QoL, although the key factor may be the application context (community vs. institution), with better results of group RT in institutionalized patients.
Group RT was associated with an effect on communication both after the intervention and at follow-up. This effect was not replicated in individual RT, with uncertain results.
Finally, despite evidence of the effect of RT on mood of older people without dementia, in the case of people with dementia only a small effect on mood was found for those participants. in individual RT.
Therefore, this research proposal aims to evaluate the ability of individual RT using a simple reminiscence format to improve the overall cognitive function, memory, executive function, mood and quality of life (QoL) of people with neurocognitive disorder attending social responses for the elderly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Reminiscence TherapyParticipants who meet the inclusion criteria will be randomly assigned to the intervention group receiving Reminiscence Therapy or to a control group receiving treatment as usual. Participants in the intervention group will participate in two Reminiscence Therapy sessions per week for 3 months besides their treatment as usual. The sessions will be based on the Book of Past and Present and they will follow the same protocol in every participant institution. |
| Control Group | No intervention | –Participants assigned to the control group will maintain their usual treatment in the institution, participating in the activities previously assigned to their individual care plan. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Having a diagnostic of a neurocognitive disorder according to the DSM-5 criteria.
- To have delivered the informed consent of the project, duly completed and signed, after prior information
- Capacity to communicate and understand.
- Possibility of gathering information about the participant's life history through their relatives or habitual caregivers, using the socio-familiar questionnaire design for that purpose.
- Being 65 years of age or older.
Key exclusion criteria (6 listed)
- To suffer from an acute or severe illness that makes it impossible for them to participate in the intervention sessions.
- Serious sensory and physical limitations that prevent the participation in the sessions.
- Severe disconnection with the environment and very limited attention span.
- Presence of severe neuropsychiatric symptoms, such as hyperactivity, psychosis, severe depressive and anxiety symptoms and apathy, that prevent participation in the sessions or presence of uncontrolled delirium.
- Traumatic life history or marked by negative events relevant to the person that discourage the participation in the Reminiscence Therapy sessions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reminiscence TherapyIntervention group will receive two Reminiscence Therapy sessions per week for 3 months. Reminiscence therapy sessions will last approximately 50 minutes and will be developed according to the following structure: * Welcome to the patient and reality orientation therapy (7 minutes) * Conducting the main activity of reminiscence (40 minutes) * Closure, thank you for the participation and farewell until the next session (3 minutes) Reminiscence therapy sessions will have an individual format and will be conducted by a therapist previously trained in the protocol and the principles of Reminiscence Therapy. The Reminiscence activities of each session will be carried out following the protocol proposed in the Book of Past and Present. | Other | Intervention Group |
Primary outcome
Cognitive functioning evaluated through Mini-Mental State Examination
Time frame: Pre and post-intervention (3 months)
Significant statistic improvement in the participant's test scores between pre-intervention assessment and post-intervention assessment. Mini-Mental State Examination is a brief cognitive screening test. Scores range between 0 - 30 points. Higher scores indicate better cognitive function.
4 secondary outcomes
Memory funtion evaluated through Memory Alteration Test
Time frame: Pre and post-intervention (3 months)
Executive functions evaluated through Frontal Assessment Battery
Time frame: Pre and post-intervention (3 months)
Mood evaluated through Geriatric Depression Scale -15
Time frame: Pre and post-intervention (3 months)
Quality of life evaluated through Quality of Life - Alzheimer's Disease
Time frame: Pre and post-intervention (3 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Background: PubMed 21543189Akanuma K, Meguro K, Meguro M, Sasaki E, Chiba K, Ishii H, Tanaka N. Improved social interaction and increased anterior cingulate metabolism after group reminiscence with reality orientation approach for vascular dementia. Psychiatry Res. 2011 Jun 30;192(3):183-7. doi: 10.1016/j.pscychresns.2010.11.012. Epub 2011 May 4.
- Background: PubMed 26572551Amieva H, Robert PH, Grandoulier AS, Meillon C, De Rotrou J, Andrieu S, Berr C, Desgranges B, Dubois B, Girtanner C, Joel ME, Lavallart B, Nourhashemi F, Pasquier F, Rainfray M, Touchon J, Chene G, Dartigues JF. Group and individual cognitive therapies in Alzheimer's disease: the ETNA3 randomized trial. Int Psychogeriatr. 2016 May;28(5):707-17. doi: 10.1017/S1041610215001830. Epub 2015 Nov 17.
- BackgroundApóstolo JLA, Loureiro LMJ, Reis IAC, Silva IALL, Cardoso DFB, Sfetcu R. Contribution to the adaptation of the Geriatric Depression Scale -15 into Portuguese. Revista de Enfermagem Referência IV(3): 65-73, 2014. doi: 10.12707/RIV14033.
- Background: PubMed 23429813Serrani Azcurra DJ. A reminiscence program intervention to improve the quality of life of long-term care residents with Alzheimer's disease: a randomized controlled trial. Braz J Psychiatry. 2012 Dec;34(4):422-33. doi: 10.1016/j.rbp.2012.05.008.
- Background: PubMed 23534370Barrios H, Verdelho A, Narciso S, Goncalves-Pereira M, Logsdon R, de Mendonca A. Quality of life in patients with cognitive impairment: validation of the Quality of Life-Alzheimer's Disease scale in Portugal. Int Psychogeriatr. 2013 Jul;25(7):1085-96. doi: 10.1017/S1041610213000379. Epub 2013 Mar 27.
- Background: PubMed 19896760Caddell LS, Clare L. The impact of dementia on self and identity: a systematic review. Clin Psychol Rev. 2010 Feb;30(1):113-26. doi: 10.1016/j.cpr.2009.10.003.
- Background: PubMed 27521377Charlesworth G, Burnell K, Crellin N, Hoare Z, Hoe J, Knapp M, Russell I, Wenborn J, Woods B, Orrell M. Peer support and reminiscence therapy for people with dementia and their family carers: a factorial pragmatic randomised trial. J Neurol Neurosurg Psychiatry. 2016 Nov;87(11):1218-1228. doi: 10.1136/jnnp-2016-313736. Epub 2016 Aug 12.
- Background: PubMed 24599812Dempsey L, Murphy K, Cooney A, Casey D, O'Shea E, Devane D, Jordan F, Hunter A. Reminiscence in dementia: a concept analysis. Dementia (London). 2014 Mar 1;13(2):176-92. doi: 10.1177/1471301212456277. Epub 2012 Aug 17.
- Background: PubMed 11113214Dubois B, Slachevsky A, Litvan I, Pillon B. The FAB: a Frontal Assessment Battery at bedside. Neurology. 2000 Dec 12;55(11):1621-6. doi: 10.1212/wnl.55.11.1621.
- Background: PubMed 1202204Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
- Background: PubMed 25765779Gonzalez J, Mayordomo T, Torres M, Sales A, Melendez JC. Reminiscence and dementia: a therapeutic intervention. Int Psychogeriatr. 2015 Oct;27(10):1731-7. doi: 10.1017/S1041610215000344. Epub 2015 Mar 13.
- Background: PubMed 19595856Haight BK, Gibson F, Michel Y. The Northern Ireland life review/life storybook project for people with dementia. Alzheimers Dement. 2006 Jan;2(1):56-8. doi: 10.1016/j.jalz.2005.12.003.
- Individual participant dataSharing planned: No
Related trials for Cognitive Impairment
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susana I Justo Henriques, PhD principal investigator
Cediara and University of de Santiago de Compostela
Enrique Pérez Sáez, PhD principal investigator
CRE Alzheimer and University of Salamanca
João L Alves Apóstolo, PhD principal investigator
Nursing School of Coimbra
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reminiscence Therapy in people with Cognitive Impairment and Cognitive Decline, run by Rsocialform - Geriatria, Lda at 25 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive functioning evaluated through Mini-Mental State Examination (time frame: Pre and post-intervention (3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04047238, which also lists 39 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2020.